Avastin/FOLFIRI in Combination With Curcumin in Colorectal Cancer Patients With Unresectable Metastasis

Phase 2

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Avastin/FOLFIRI; Dietary Supplement: Curcumin

• Registration Number: NCT02439385
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

Oral curcumin-containing supplement will be given to colorectal cancer patients with unresectable metastases who will be starting Avastin/FOLFIRI chemotherapy for up to completion of (or withdrawal from) chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-02
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Study Start: 2015-08-24
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-28
• Last Update Posted: 2022-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Age : 20 Years and older
• Histologically confirmed adenocarcinoma of the colon or rectum
• Patients with primary colon or rectal cancer and unresectable metastatic lesions.
• Patients with no primary cancer related symptoms.
• ECOG performance status of 0 - 2
• Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl)
• ASA score of < 3
• An informed consent form has been signed by the patient.

Exclusion Criteria

• Colorectal cancer other than adenocarcinoma
• The patient received adjuvant chemotherapy within the past 6 months.
• The patient received chemotherapy for metastatic colon cancer.
• The patient was planning to have curative surgery for the metastatic lesions.
• Patients with peritoneal carcinomatosis.
• Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated.
• ASA score of > 4
• The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate.
• Patients with an active infection, which need antibiotic therapy, during the randomization period.
• Pregnant or breastfeeding women
• Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avastin/FOLFIRI with curcumin	Avastin/FOLFIRI	Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement
Avastin/FOLFIRI with curcumin	Curcumin	Patients will receive first line Avastin/FOLFIRI in combination with curcumin-containing supplement

Primary Outcome Measures

Name	Time	Method
Progression-free survival	2 years	The primary end point of this study is to evaluate progression-free survival in colorectal cancer patients with unresectable metastasis after treatment with first line Avastin/FOLFIRI in combination with a dietary supplement of nanostructured lipid curcumin particle (Aju Pharm, Korea), which improved biotransformation and bioavailability profiles of curcumin.

Secondary Outcome Measures

Name	Time	Method
Overall survival rate	3 years	Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months. Overall survival will be measured in months.
Overall response rate	2 years	According to RECIST criteria v1.1
Safety (assessed by toxicity grades defined by NCI-CTCAE (version 4.0)	2 years	Safety as assessed by toxicity grades defined by NCI-CTCAE (version 4.0)
Quality of life (QoL)	2 years	QoL measured by the FACT-G (version 4, Korean version)
Fatigue (FACIT-Fatigue scale (version 4, Korean version)	2 years	Fatigue measured by the FACIT-Fatigue scale (version 4, Korean version)